Kevzara 200 mg/1.14 ml

Informazioni principali

  • Nome commerciale:
  • Kevzara 200 mg/1.14 ml soluzione iniettabile in siringa preriempita
  • Forma farmaceutica:
  • soluzione iniettabile in siringa preriempita
  • Composizione:
  • sarilumabum 200 mg, L-histidinum tue histidini hydrochloridum monohydricum, L-arginini hydrochloridum, saccarosio, polysorbatum 20, aqua ad iniectabilia q s. annuncio solutionem pro 1.14 ml.
  • Utilizzare per:
  • Esseri umani
  • Tipo di medicina:
  • Farmaco biologico

Documenti

  • per i professionisti:
  • Il foglio illustrativo per questo prodotto non è al momento disponibile, é possibile inviare una richiesta al nostro Servizio Clienti ed essere avvisati nel momento in cui è disponibile sulla nostra piattaforma.


    Richiedi il foglio illustrativo per i professionisti.

Localizzazione

  • Disponibile in:
  • Kevzara 200 mg/1.14 ml soluzione iniettabile in siringa preriempita
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Biotechnologika
  • Area terapeutica:
  • L'artrite reumatoide

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 66424
  • Data dell'autorizzazione:
  • 20-04-2018
  • Ultimo aggiornamento:
  • 19-10-2018

Foglio illustrativo

Patienteninformation

Kevzara® 150 mg siringa preriempita

Che cos’è Kevzara e quando si usa?

Kevzara contiene il principio attivo sarilumab, un anticorpo monoclonale (un tipo di proteina

specializzata) che blocca l'azione di una proteina denominata interleuchina-6 (IL-6). L'IL-6 gioca un

ruolo importante nel manifestarsi di sintomi della poliartrite reumatoide quali dolore, gonfiore

articolare, rigidità mattutina e affaticamento.

Kevzara serve per trattare pazienti adulti affetti da poliartrite reumatoide attiva da moderata a severa

nel caso in cui le terapie con farmaci antireumatici precedenti non abbiano dato risultati soddisfacenti

o non siano tollerate. Kevzara può essere utilizzato da solo o insieme ad altri medicamenti, secondo

le indicazioni del suo medico.

Kevzara può rallentare i danni causati alle articolazioni e migliorare la capacità di affrontare le

attività quotidiane.

Quando non si può assumere Kevzara?

Non assuma Kevzara:

·se è allergico al sarilumab o a uno qualsiasi degli altri componenti di questo medicamento (vedi

sezione «cosa contiene Kevzara? »);

·se ha un'infezione grave attiva.

Quando è richiesta prudenza nell’uso di Kevzara?

Informi immediatamente il suo medico se presenta una reazione di ipersensibilità che dovesse

manifestarsi con orticaria, rossore o eruzione cutanea in prossimità del sito di iniezione di Kevzara. Il

suo medico deciderà se deve interrompere il trattamento.

Informi il suo medico nel caso in cui:

·soffre di una qualsiasi infezione o se ha spesso infezioni. Kevzara può ridurre la capacità

dell'organismo di combattere le infezioni e il trattamento potrà renderla più suscettibile alle infezioni

o farà peggiorare eventuali infezioni di cui soffre;

·ha la tubercolosi, sintomi della tubercolosi (tosse persistente, perdita di peso, svogliatezza, febbre

lieve) o è stato a stretto contatto con una persona affetta da tubercolosi. Prima di usare Kevzara, il

suo medico la visiterà o eseguirà un test cutaneo per ricercare la presenza di tubercolosi;

·ha avuto un'epatite virale o un'altra malattia epatica (che interessa il fegato). Prima di usare Kevzara,

il suo medico effettuerà un esame del sangue per controllare la funzionalità del suo fegato;

·ha avuto una diverticolite (infiammazione del colon) o un'ulcera allo stomaco/all'intestino oppure ha

sviluppato sintomi quali febbre e dolori allo stomaco (addominali) persistenti;

·ha avuto qualsiasi tipo di cancro;

·è stato sottoposto recentemente a vaccinazione o ha in programma di farsi vaccinare.

Il suo medico effettuerà degli esami del sangue prima del primo utilizzo di Kevzara e durante il

trattamento per verificare se ha una bassa conta di globuli bianchi, una diminuzione della percentuale

di piastrine, un innalzamento del livello di enzimi epatici o alterazioni dei livelli di colesterolo.

Capacità di condurre un veicolo e di utilizzare attrezzi o macchine

Finora non è noto se l'assunzione di Kevzara comprometta la capacità di guidare veicoli e usare

macchinari.

Informi il suo medico o il suo farmacista se sta usando, ha recentemente usato o potrebbe usare

qualsiasi altro medicamento. Si sconsiglia l'utilizzo di Kevzara in associazione con un gruppo di

medicamenti denominati inibitori delle JAK o con altri medicamenti biologici utilizzati nel

trattamento della poliartrite reumatoide.

Kevzara può influire sull'azione di alcuni medicamenti; pertanto la posologia di tali medicamenti

potrà richiedere un aggiustamento. Informi il suo medico se sta assumendo uno dei medicamenti

seguenti:

·statine, utilizzate per ridurre il livello di colesterolo,

·contraccettivi orali,

·teofillina, utilizzata per curare l'asma,

·warfarina, utilizzata per prevenire i coaguli di sangue.

Informi il suo medico o il suo farmacista nel caso in cui:

·soffre di altre malattie,

·soffre di allergie.

Si può assumere Kevzara durante la gravidanza o l’allattamento?

Kevzara non deve essere assunto se è in corso una gravidanza, a meno che il suo medico non l'abbia

espressamente consigliato. Gli effetti di Kevzara sul feto non sono noti. Pertanto è consigliabile

utilizzare metodi contraccettivi durante il trattamento con Kevzara e fino a 3 mesi dopo

l'interruzione. Informi il suo medico se è incinta o c'è la possibilità di una gravidanza.

Non è noto se Kevzara passi nel latte materno. Dopo averne parlato con il suo medico, potrà decidere

di allattare o di sospendere il trattamento con Kevzara oppure di non allattare e di continuare il

trattamento con Kevzara.

Come usare Kevzara?

Prenda sempre questo medicamento seguendo esattamente il presente foglietto illustrativo e le

istruzioni per l'uso (riportate in fondo al presente foglietto) o come indicato dal suo medico o dal suo

farmacista. In caso di dubbio consulti il suo medico, il farmacista o l'infermiere.

Che dose iniettare e quando procedere all'iniezione?

La dose raccomandata è di 200 mg una volta ogni due settimane. Il suo medico potrà aggiustare la

dose del medicamento in base ai risultati degli esami del sangue o alla sua risposta al trattamento.

Deve essere iniettata tutta la quantità contenuta nella siringa.

Dove deve essere praticata l'iniezione del medicamento?

Kevzara si inietta nella pelle (somministrazione sottocutanea) dell'addome, della coscia o della parte

superiore del braccio.

Scelga ogni volta un sito diverso per l'iniezione (ad es. coscia destra e poi coscia sinistra, lato destro

e poi lato sinistro dell'addome).

Non pratichi l'iniezione in zone dove la pelle è delicata, danneggiata, presenta lividi o cicatrici.

Lasci che Kevzara raggiunga la temperatura ambiente prima dell'utilizzo.

Come utilizzare la siringa preriempita

Il medico, il farmacista o l'infermiere le mostreranno come iniettare Kevzara prima di utilizzare la

siringa per la prima volta.

·Legga sempre le istruzioni per l'uso riportate in fondo al presente foglietto illustrativo.

·Utilizzi sempre la siringa come descritto nelle istruzioni per l'uso.

Se inietta più Kevzara di quanto deve

Se ha utilizzato più Kevzara di quanto dovrebbe, ne parli con il suo medico o con il suo farmacista.

Se dimentica di iniettare Kevzara

·Se sono passati 1, 2 o 3 giorni dall'ultima iniezione, inietti l'iniezione saltata appena può, quindi

inietti la dose successiva seguendo la posologia iniziale.

·Se sono passati 4 giorni o più dall'iniezione o se ha dei dubbi sul giorno in cui deve iniettarsi la dose

di Kevzara successiva, proceda con l'iniezione alla data successiva pianificata inizialmente.

·Non raddoppi mai la dose per nessun motivo! Se ha domande, si rivolga al suo medico, al farmacista

o all'infermiere.

Se interrompe l'uso di Kevzara

Non interrompa l'uso di Kevzara senza avere prima consultato il suo medico.

Non modifichi di sua iniziativa la posologia prescritta. Se ritiene che l'azione del medicamento sia

troppo debole o troppo forte, ne parli con il suo medico o con il suo farmacista.

Bambini e adolescenti (di età inferiore a 18 anni)

L'utilizzo di Kevzara nei bambini e negli adolescenti di età inferiore a 18 anni non è stato ancora

studiato. Si sconsiglia pertanto l'utilizzo di Kevzara in questa fascia d'età.

Se ha altre domande sull'uso di questo medicamento, consulti il suo medico o il suo farmacista.

Quali effetti collaterali può avere Kevzara?

Come tutti i medicamenti, anche Kevzara può avere effetti indesiderati, che tuttavia non si

presentano sistematicamente in tutte le persone.

Informi immediatamente il suo medico se ritiene di avere un'infezione. Questi sintomi possono

comprendere febbre, sudorazione o brividi.

Molto frequenti (possono interessare più di 1 persona su 10)

·Bassa conta dei globuli bianchi rilevata dagli esami del sangue (neutropenia)

Frequenti (possono interessare fino a 1 persona su 10)

·Infezioni delle vie respiratorie superiori

·Infezione delle vie urinarie

·Congestione nasale, gola irritata e naso che cola

·Vescicole (herpes labiale)

·Bassa conta delle piastrine (un tipo di cellule del sangue) rilevata dagli esami del sangue

·Colesterolo alto

·Trigliceridi alti (un tipo di grassi)

·Prove di funzionalità epatica anormali

·Reazioni in sede di iniezione (compresi arrossamento e sensazione di prurito)

Informi il suo medico o il suo farmacista se osserva effetti collaterali qui non descritti.

Di che altro occorre tener conto?

Tenere al di fuori della vista e della portata dei bambini.

Il medicamento non dev'essere utilizzato oltre la data di scadenza indicata con «SCAD» sull'etichetta

e sulla confezione. La data di scadenza si riferisce all'ultimo giorno del mese indicato.

Conservare la siringa nella confezione originale al riparo dalla luce.

Conservare in frigorifero (2-8 °C). Non congelare e non riscaldare il prodotto.

Una volta estratto dal frigorifero, Kevzara può essere conservato a una temperatura al di sotto di

25 °C per 14 giorni al massimo. Trascorso tale periodo, la siringa deve essere obbligatoriamente

gettata se non è stata utilizzata.

La soluzione è limpida, da incolore a giallo pallido. Non utilizzare il medicamento se la soluzione ha

cambiato colore, se è torbida o se contiene particelle visibili.

La siringa di Kevzara deve essere utilizzata una sola volta.

Cosa contiene Kevzara?

Il principio attivo è sarilumab. Gli altri componenti (eccipienti) sono: istidina, arginina, polisorbato

20, saccarosio e acqua per preparazione iniettabile.

Ogni siringa preriempita contiene 1,14 ml di soluzione che costituisce una dose singola di 150

milligrammi (131,6 milligrammi per ml) di sarilumab.

Numero dell’omologazione

66424 (Swissmedic).

Dove è ottenibile Kevzara? Quali confezioni sono disponibili?

In farmacia, dietro presentazione della prescrizione medica.

Kevzara è disponibile in scatole da 2 siringhe preriempite

Titolare dell’omologazione

sanofi-aventis (svizzera) sa, 1214 Vernier/GE.

Questo foglietto illustrativo è stato controllato l'ultima volta nel luglio 2017 dall'autorità competente

in materia di medicamenti (Swissmedic).

Istruzioni per l’uso

Kevzara 150 mg, soluzione per iniezione in siringa preriempita

sarilumab

È importante leggere il foglietto illustrativo e le presenti istruzioni per l’utilizzo fino in fondo prima

di utilizzare KEVZARA. Conservi questo documento in vista del prossimo utilizzo.

Se ha domande, chieda consiglio al suo medico o al suo farmacista.

Le varie parti della siringa preriempita di Kevzara sono illustrate in questa immagine.

Informazioni importanti

Questo dispositivo è una siringa preriempita monodose (denominata «siringa» in queste istruzioni).

Chieda all’operatore sanitario che si occupa di lei di mostrarle il modo corretto di utilizzare la siringa

prima della prima iniezione.

Da fare

√ Tenga la confezione in una borsa termica quando è in viaggio.

√ Lasci raggiungere alla siringa la temperatura ambiente per almeno 30 minuti prima di utilizzarla.

Da evitare

Non utilizzi la siringa se è stata danneggiata o se il cappuccio grigio dell’ago manca o è staccato.

Non rimuova il cappuccio dell’ago fino a un attimo prima di essere pronto per effettuare

l’iniezione.

Non tocchi l’ago.

Non tenti di riposizionare il cappuccio sulla siringa.

Non esegua l’iniezione attraverso gli indumenti.

Passaggio A: Si prepari per l’iniezione

1. Prepari tutte le attrezzature che le serviranno su una superficie di lavoro pulita e piana.

·Occorrerà un tampone imbevuto di alcol, un batuffolo di cotone o una garza e un contenitore

resistente alle perforazioni.

·Estragga una siringa dalla confezione tenendola dal centro del corpo principale. Conservi le siringhe

rimanenti nella confezione in frigorifero.

2. Osservi l’etichetta.

·Verifichi di avere il medicamento corretto e la dose corretta.

·Controlli la data di scadenza (SCAD).

Non utilizzi la siringa se la data è stata superata.

3. Osservi il medicamento.

·Controlli che il liquido sia limpido e da incolore a giallo chiaro.

·La presenza di un’eventuale bolla d’aria è del tutto normale.

Non inietti il liquido se è torbido, se ha cambiato colore o se contiene particelle.

4. Appoggi la siringa su una superficie piana e lasci che raggiunga la temperatura ambiente per

almeno 30 minuti.

·L’uso della siringa a temperatura ambiente può rendere più confortevole l’iniezione.

Non riscaldi la siringa, lasci che si scaldi da sola.

5. Selezioni il sito di iniezione.

·Può eseguire l’iniezione sulla coscia o sulla pancia (addome), ad eccezione dei 5 cm circostanti

l’ombelico. Se è un’altra persona a praticare l’iniezione, è possibile utilizzare anche l’area esterna

della parte alta del braccio.

·Cambi sito di iniezione ogni volta che effettua l’iniezione.

Non effettui l’iniezione su pelle sensibile, danneggiata o se presenta ecchimosi o cicatrici.

6. Prepari il sito di iniezione.

·Si lavi le mani.

·Deterga la pelle con un tampone imbevuto di alcool.

Non tocchi più il sito di iniezione prima dell’iniezione.

Passaggio B: Effettui l’iniezione – esegua il passaggio B solo dopo aver completato il passaggio A

«Si prepari per l’iniezione»

1. Tolga il cappuccio dell’ago.

·Tenga la siringa dal centro del corpo principale con l’ago puntato lontano da sé.

·Tenga la mano distante dallo stantuffo.

Non elimini le bolle d’aria eventualmente contenute nella siringa.

Non tolga il cappuccio finché non è pronto a eseguire l’iniezione.

Non rimetta il cappuccio sull’ago.

2. Sollevi la pelle con due dita.

·Con il pollice e l’indice afferri la pelle del sito di iniezione per formare una piega.

3. Inserisca l’ago nella piega della pelle con un’angolazione di circa 45°.

4. Spinga lo stantuffo verso il basso.

·Spinga lentamente lo stantuffo verso il basso fino a fine corsa finché la siringa non sarà

completamente vuota.

5. Prima di estrarre l’ago, verifichi che la siringa sia vuota.

·Estragga l’ago alla stessa angolazione a cui era stato inserito.

·Se vede del sangue, prema con un batuffolo di cotone o una garza sul sito di iniezione.

Non strofini la pelle dopo l’iniezione.

6. Collochi la siringa utilizzata e il cappuccio in un contenitore resistente alle perforazioni.

·Collochi la siringa utilizzata e il cappuccio in un recipiente resistente alle perforazioni

immediatamente dopo l’uso.

·Tenga sempre il contenitore fuori dalla vista e dalla portata dei bambini.

Non rimetta il cappuccio sull’ago.

Non getti le siringhe utilizzate nei rifiuti domestici.

Non ricicli il contenitore resistente alle perforazioni.

Non smaltisca il contenitore resistente alle perforazioni nei rifiuti domestici. Chieda al suo medico

o al suo farmacista come smaltire il contenitore.

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Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release

Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release

Vaccine lot release information updated on 3/3/2010.

FDA - U.S. Food and Drug Administration

9-11-2018

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

These vaping products do not meet requirements of the Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001) under the Canada Consumer Product Safety Act.

Health Canada

7-11-2018

Nature's Ultimate recalls NuWrench and NuStainless Products

Nature's Ultimate recalls NuWrench and NuStainless Products

The recalled products are not provided with the required child-resistant containers required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

7-11-2018

Murray Wholesale Cash & Carry recalls King Universal Butane Fuel

Murray Wholesale Cash & Carry recalls King Universal Butane Fuel

The recalled products do not have proper hazard labelling as required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

6-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Published on: Fri, 02 Nov 2018 00:00:00 +0100 The applicant BASF SE submitted a request to the competent national authority in Belgium to evaluate the confirmatory data that were identified for kresoxim‐methyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the confirmatory data requirement, a new study on the storage stability of kresoxim‐methyl residues in animal matrices was submitted. The data gap was considered ...

Europe - EFSA - European Food Safety Authority Publications

6-11-2018

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Published on: Fri, 02 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the Australian Government Department of Agriculture and Water Resources submitted two requests to the competent national authority in Denmark to set import tolerances for the active substance haloxyfop‐P in linseed and rapeseed. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for linseed and rapeseed. Adequate analytical metho...

Europe - EFSA - European Food Safety Authority Publications

5-11-2018

Vanpak Limited recalls David Ross Extra purified Butane gas

Vanpak Limited recalls David Ross Extra purified Butane gas

The recalled products do not have proper hazard labelling as required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act. Improper labelling could result in unintentional exposure to these products and lead to serious illness, injury or death.

Health Canada

1-11-2018

Pest categorisation of Conotrachelus nenuphar

Pest categorisation of Conotrachelus nenuphar

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The EFSA Panel on Plant Health performed a pest categorisation of Conotrachelus nenuphar (Herbst) (Coleoptera: Curculionidae), for the EU. C. nenuphar is a well‐defined species, recognised as a serious pest of stone and pome fruit in the USA and Canada where it also feeds on a range of other hosts including soft fruit (e.g. Ribes,Fragaria) and wild plants (e.g. Crataegus). Adults, which are not good flyers, feed on tender twigs, flower buds and leaves. Femal...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Pest categorisation of Acrobasis pirivorella

Pest categorisation of Acrobasis pirivorella

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The European Commission requested EFSA to conduct a pest categorisation of Acrobasis pirivorella (Lepidoptera: Pyralidae), a monophagous moth whose larvae exclusively feed on developing buds, flowers, and fruits of cultivated and wild Pyrus spp. A. pirivorella is a species with reliable methods available for identification. A. pirivorellaoccurs in north‐east Asia only, causing significant damage in cultivated pears. It is regulated in the EU by Council Direc...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Published on: Tue, 30 Oct 2018 00:00:00 +0100 In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received a mandate from the European Commission to provide an update of the reasoned opinion on the review of existing maximum residue levels (MRLs) for imazalil published on 5 September 2017, taking into account the additional information provided on the toxicity of the metabolites R014821, FK‐772 and FK‐284. EFSA did not derive MRL proposals from the post‐harvest uses reported on citrus fru...

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

Pest categorisation of Sternochetus mangiferae

Pest categorisation of Sternochetus mangiferae

Published on: Mon, 29 Oct 2018 00:00:00 +0100 The European Commission requested EFSA to conduct a pest categorisation of Sternochetus mangiferae (Coleoptera: Curculionidae), a monophagous pest weevil whose larvae exclusively feed on mango seeds, whereas adults feed on mango foliage. S. mangiferae is a species with reliable methods available for identification. It is regulated in the EU by Council Directive 2000/29/EC where it is listed in Annex IIB as a harmful organism whose introduction into EU Protec...

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

Pest categorisation of Aleurocanthus spp.

Pest categorisation of Aleurocanthus spp.

Published on: Mon, 29 Oct 2018 00:00:00 +0100 The Panel on Plant Health performed a pest categorisation of Aleurocanthus spp., a well‐defined insect genus of the whitefly family Aleyrodidae (Arthropoda: Hemiptera). Difficulties within the taxonomy of the genus give doubt about the ability to accurately identify some members to species level. Nevertheless, the genus is thought to currently include about ninety species mainly reported from tropical and subtropical areas. The genus is listed in Council Dir...

Europe - EFSA - European Food Safety Authority Publications

25-10-2018

BLL Enterprises Inc. recalls Fluid Film Rust & Corrosion Protection Aerosol

BLL Enterprises Inc. recalls Fluid Film Rust & Corrosion Protection Aerosol

The recalled products do not have proper hazard labelling required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

23-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pendimethalin

Evaluation of confirmatory data following the Article 12 MRL review for pendimethalin

Published on: Mon, 22 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residue trials on strawberries, onions, garlic, tomatoes, peppers, cucumbers, artichokes, leeks and rape seeds were submitted. The data gaps are considere...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for dimethomorph

Evaluation of confirmatory data following the Article 12 MRL review for dimethomorph

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for dimethomorph in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted residue data on raspberries were satisfactorily addressing the data gaps on raspberries and blackberries. Considering the new information provided, it is appropri...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant, Nichino Europe Co. Ltd., submitted application request to the competent national authority in the Netherlands to evaluate confirmatory data that were identified for pyraflufen‐ethyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted data were sufficient to confirm the MRLs for citrus fruits, tree nuts, pome fruits, stone fruits, table and wine grapes, curra...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 74 flavouring substances from subgroup 1.1.1 of FGE.19 in the Flavouring Group Evaluation 200 Revision 1 (FGE.200 Rev1). In FGE.200, genotoxicity studies were provided for one representative substance, namely hex‐2(trans)‐enal [FL‐no: 05.073], and for other two substances in the same subgroup, namely 2‐dodecenal [FL‐no: 05.03...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Pest categorisation of Stagonosporopsis andigena

Pest categorisation of Stagonosporopsis andigena

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The Panel on Plant Health performed a pest categorisation of Stagonosporopsis andigena, the causal agent of black blight of potato, for the EU. The pest is a well‐defined fungal species and reliable methods exist for its detection and identification. S. andigena is present in Bolivia and Peru. The pest is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC as Phoma andina, meaning its introduction into the EU is prohibited. The ma...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Pest categorisation of Thecaphora solani

Pest categorisation of Thecaphora solani

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The Panel on Plant Health performed a pest categorisation of the fungus Thecaphora solani, the causal agent of smut of potato, for the EU. The identity of the pest is well established and reliable methods exist for its detection and identification. T. solaniis present in Bolivia, Chile, Colombia, Ecuador, Mexico, Panama, Peru and Venezuela. The pathogen is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC, meaning its introducti...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum, which are well‐defined and distinguishable tree fungal pathogens of the family Cronartiaceae. In 2018, these species were moved from the genus Endocronartium to the genus Cronartium. These pathogens are not known to be present in the EU and are regulated in Council Directive 2...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Published on: Mon, 15 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant, BASF SE, submitted an application to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance mepiquat in cotton seeds. The data submitted in support of the application were found to be sufficient to derive a MRL proposal for cotton seeds and the previously derived MRL proposals for animal commodities were found to be stil...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Melampsora farlowii

Pest categorisation of Melampsora farlowii

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Melampsora farlowii, a well‐defined and distinguishable fungus of the family Melampsoraceae. M. farlowii is the causal agent of a leaf and twig rust of hemlocks (Tsuga spp.) in eastern North America. The pathogen is regulated in Council Directive 2000/29/EC (Annex IAI) as a harmful organism whose introduction into the EU is banned. M. farlowii ...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Published on: Mon, 15 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in United Kingdom to evaluate the confirmatory data that were identified for teflubenzuron in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new metabolism study on leafy crops, a study investigating the nature of residues under standard hydrolytic conditions and a validated ...

Europe - EFSA - European Food Safety Authority Publications

6-10-2018

Modification of the existing maximum residue level for epoxiconazole in beetroots

Modification of the existing maximum residue level for epoxiconazole in beetroots

Published on: Fri, 05 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Agriculture & Horticulture Development Board submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue level (MRL) for the active substance epoxiconazole in beetroots. The data submitted in support of the request were found to be sufficient to derive a MRL proposal for beetroots. Adequate analytical methods for enforcement are...

Europe - EFSA - European Food Safety Authority Publications

2-10-2018

Review of the existing maximum residue levels for cyflufenamid according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for cyflufenamid according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 01 Oct 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance cyflufenamid. To assess the occurrence of cyflufenamid residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (in...

Europe - EFSA - European Food Safety Authority Publications

28-9-2018

Peer review of the pesticide risk assessment of the active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

Peer review of the pesticide risk assessment of the active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

Published on: Thu, 27 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, France, for the pesticide active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623) are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

General Finishes Recalls Outdoor Oil

General Finishes Recalls Outdoor Oil

The recalled products do not have the proper consumer chemical hazard packaging and labelling required by the consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

27-9-2018

Review of the existing maximum residue levels for tembotrione according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for tembotrione according to Article 12 of Regulation (EC) No 396/2005

Published on: Wed, 26 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tembotrione. To assess the occurrence of tembotrione residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011 as well as the import tolerances and European author...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

Outcome of the consultation on confirmatory data used in risk assessment for the active substance  copper (I), copper (II) variants

Outcome of the consultation on confirmatory data used in risk assessment for the active substance copper (I), copper (II) variants

Published on: Wed, 26 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following the first approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Me...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

Modification of the existing maximum residue level for flonicamid in various crops

Modification of the existing maximum residue level for flonicamid in various crops

Published on: Tue, 25 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dienstleistungszentrum Ländlicher Raum submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance flonicamid in radishes. Furthermore, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in the Ne...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Published on: Tue, 25 Sep 2018 00:00:00 +0200 Abstract Following a notification from Sorghum Zrt., submitted to the European Commission under Article 14 of Regulation (EU) 2015/2283 to place on the market syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country (TF), and in line with Article 15(2) of that Regulation, EFSA was asked by the European Commission whether there are duly reasoned safety objections to the placing on the market of the TF within the European Union. The ap...

Europe - EFSA - European Food Safety Authority Publications

25-9-2018

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

The recalled products have not been properly classified according to the Consumer Chemicals and Containers Regulations, 2001, in order to ensure appropriate hazard labelling. These regulations are empowered by the Canada Consumer Product Safety Act. Improper labelling could result in unintentional exposure to these products and lead to serious illness, injury or death.

Health Canada

24-9-2018

Tegemoetkoming Q-koorts

Tegemoetkoming Q-koorts

Het kabinet stelt € 14,5 miljoen beschikbaar als tegemoetkoming voor mensen met de diagnose chronische Q-koorts, Q-koorts­vermoeidheids­syndroom (QVS) of met een QVS gelijkend ziektebeeld. Ook de nabestaanden van overleden chronische Q-koortspatiënten kunnen in aanmerking komen voor een tegemoetkoming.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

21-9-2018

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Published on: Thu, 20 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member State...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue level for clothianidin in potatoes

Published on: Thu, 20 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience AG submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance clothianidin to accommodate the use on potatoes imported from Canada. The data submitted in support of the request were found to be sufficient to derive a MRL proposal. Adequate analytical methods for enforcement are availa...

Europe - EFSA - European Food Safety Authority Publications

20-9-2018

Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump (IABP) For Interruption and/or Inability to Start Therapy at Altitudes above 3,200 Feet/975 Meters

Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump (IABP) For Interruption and/or Inability to Start Therapy at Altitudes above 3,200 Feet/975 Meters

Getinge is voluntarily initiating a Worldwide recall involving a field correction of approximately 5,223 Maquet/Getinge Cardiosave Intra-Aortic Balloon Pumps (IABP) sold by Datascope Corp., for a potential interruption and/or inability to start therapy to the patient regarding the use of certain Intra-Aortic Balloons (IABs) prior to or during the use with Cardiosave IABP for users who are at altitudes above 3200 feet/975 meters. This condition could potentially lead to patient hemodynamic instability.

FDA - U.S. Food and Drug Administration

19-9-2018

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant LTZ Augustenberg submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance potassium phosphonates in raspberries, blackberries, currants, blueberries, gooseberries and elderberries. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all crops under c...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

Modification of the existing maximum residue levels for flonicamid in various root crops

Modification of the existing maximum residue levels for flonicamid in various root crops

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the Agriculture and Horticulture Development Council submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance flonicamid in beetroots, carrots, celeriacs/turnip rooted celeries, horseradishes, Jerusalem artichokes, parsnips, parsley roots/Hamburg roots parsley, radishes, salsifies, swedes/rutabagas, tu...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

Published on: Tue, 18 Sep 2018 00:00:00 +0200 During the years 2012‐2016, the Dutch National Food Consumption survey was conducted in the Netherlands. For the survey, a random sample was drawn from consumer panels stratified by age and gender and maintained representative to the population with regard to region, address density and educational level. Complete results were obtained for 4,313 persons (response rate 65%); including toddlers, children, adolescents, adults and elderly. Pregnant or lactating ...

Europe - EFSA - European Food Safety Authority Publications

18-9-2018

Xtava recalls Allure and Allure Pro 2200W ionic ceramic hair dryers

Xtava recalls Allure and Allure Pro 2200W ionic ceramic hair dryers

The hair dryer and power cord can overheat and catch on fire, posing fire, burn and electrical shock hazards.

Health Canada

18-9-2018

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Published on: Fri, 14 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Austria for the pesticide active substance sodium hydrogen carbonate are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of sodium hyd...

Europe - EFSA - European Food Safety Authority Publications

18-9-2018

Peer review of the pesticide risk assessment of the active substance beta‐cyfluthrin

Peer review of the pesticide risk assessment of the active substance beta‐cyfluthrin

Published on: Fri, 14 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Germany and co‐rapporteur Member State Hungary for the pesticide active substance beta‐cyfluthrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of b...

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

EU/3/14/1250 (Akcea Therapeutics UK Ltd)

EU/3/14/1250 (Akcea Therapeutics UK Ltd)

EU/3/14/1250 (Active substance: Phosphorothioate oligonucleotide targeted to transthyretin) - Transfer of orphan designation - Commission Decision (2018)7282 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/098/13/T/01

Europe -DG Health and Food Safety

22-10-2018

Pemetrexed Hospira (Pfizer Europe MA EEIG)

Pemetrexed Hospira (Pfizer Europe MA EEIG)

Pemetrexed Hospira (Active substance: pemetrexed) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6971 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3970/T/14

Europe -DG Health and Food Safety

2-10-2018

Imraldi (Samsung Bioepis UK Limited)

Imraldi (Samsung Bioepis UK Limited)

Imraldi (Active substance: adalimumab) - Centralised - 2-Monthly update - Commission Decision (2018)6458 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4279/IB/14

Europe -DG Health and Food Safety

2-10-2018

EU/3/14/1242 (Neurolixis SAS)

EU/3/14/1242 (Neurolixis SAS)

EU/3/14/1242 (Active substance: 3-Chloro-4-fluorophenyl-[4-fluoro-4-{[(5-methylpyrimidin-2-ylmethyl) amino]methyl}piperidin-1-yl]methanone) - Transfer of orphan designation - Commission Decision (2018)6436 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/163/13/T/01

Europe -DG Health and Food Safety

17-9-2018

Scientific guideline:  Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

Scientific guideline: Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

The Guideline on the investigation of medicinal products in the term and preterm neonates was prepared during the period from 2007 to 2009 and came into effect in 2010 (EMEA/536810/2008). Considerable experience of assessing PIP applications covering neonatal age subset has been gained since then and it has become apparent that some essential questions arise repeatedly during the assessment of Paediatric Investigation Plans (PIP) applications for products intended to be investigated and used in neonates....

Europe - EMA - European Medicines Agency